This observational cohort study is being conducted to further characterize selected adverse events of interest among a patient population with osteoporosis who are prescribed bazedoxifene, raloxifene, or a bisphosphonate in usual clinical care outside of a randomized clinical trial setting. The study will compare the rates of the selected clinical events among the three treatment groups.

Patients receiving Bazedoxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.

Primary Comparator

Drug: Bisphosphonate

Patients receiving Bisphosphonates in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.

Secondary Comparator

Drug: Raloxifene

Patients receiving Raloxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.

Detailed Description:

All women in the database meeting the inclusion criteria will be included in the study without any statistical sampling.

Eligibility

Ages Eligible for Study:

45 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

Women aged 45 or over who have records of receiving bazedoxifene, bisphosphonates or raloxifene in the Cegedim database in Italy and Spain.

Criteria

Inclusion Criteria:

Female

At least one prescription for bazedoxifene, raloxifene, or any bisphosphonate during the study inclusion period (index prescription);

A recoded diagnosis code of osteoporosis on or within 60 days prior to the index prescription date;

Age >=45 at the date of the index prescription; and

At least 6-months of follow-up data in the electronic medical record system prior to the date of the index prescription

Exclusion Criteria:

There is no exclusion criteria. All women in the database who meet the inclusion criteria will be studied.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416194